Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
Track
:
Track 19: Communities Showcase
Program Code:
362
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
205A
CHAIR
:
Melvyn Greberman, MD,MPH,MS,FACPM (SCHNON), President, Public Health Resources, United States
As President, Public Health Resources, Dr. Greberman consults in the clinical & public health sciences, emerging technologies, regulatory affairs, & interagency & public-private sector collaboration. Before his PHS retirement, he was principal FDA representative to many such collaborative efforts.
Elektra is dermatologist by training has been a medical officer at the FDA since 2001 and with SEALD since 2007. Elektra works in clinical outcome assessment review and qualification and has participated in the development of the FDA PRO guidance as well as the DDT qualification guidance.
Stanley A. Edlavitch, PhD,MA (SPKSUP), Professor, Epidemiology, School of Medicine; Center for Behavioral Medicine, University of Missouri Kansas City, United States
Stan is Professor of Epidemiology in the Department of Psychiatry at UMKC SOM. He founded ISPE and has held leadership positions at FDA, the pharmaceutical Industry and Academia. He chairs several local and national committees addressing health planning, suicide prevention and drug safety.
J. Michael Fitzmaurice, PhD,FACMI (SPKAGY), Senior Science Advisor for Information Technology, Office of the Director, Agency for Healthcare Research and Quality (AHRQ), United States
Dr. Fitzmaurice is Senior Science Advisor for IT in the Office of the Director, AHRQ. He represents AHRQ on national and departmental committees and directs USHIK, a metadata registry of health data elements endorsed by the HHS Secretary. He advises the AHRQ Director on AHRQ's HIT programs.
Description
This session will discuss the use of patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and observer-reported outcomes (ObsROs) to assess treatment benefits in clinical trials, and collaborative ventures that support scientific, regulatory, and clinical applications in the US and other countries.
This session has been developed by the Clinical Research Community.